Amplitude Therapeutics and Lilly Team Up to Develop New taRNA Vaccines for Infectious Diseases

New Collaboration Will Focus on Vaccine Candidates for Diseases With High Unmet Need

Amplitude Therapeutics has entered into a strategic research collaboration and licensing agreement with Eli Lilly and Company to discover and develop new vaccine candidates for infectious diseases.

The collaboration will use Amplitude's trans-amplifying RNA, or taRNA, technology. The initial programs will focus on undisclosed infectious diseases where current prevention options still leave significant gaps.

Lilly will also have the option to add up to two more infectious disease targets to the collaboration.

For Amplitude, the agreement provides an opportunity to test its RNA technology across multiple vaccine programs. For Lilly, it adds access to a newer RNA platform that could potentially support the development of vaccines with flexible dosing and manufacturing options.

What Is taRNA Technology?

Amplitude's platform is based on trans-amplifying RNA, known as taRNA.

The basic idea is to separate two important RNA components instead of putting everything into a single RNA molecule.

One component provides the replicase machinery, while another carries the instructions for producing the target antigen.

This separation gives researchers more flexibility when designing vaccines.

They can adjust the antigen, change the formulation and optimize the dose depending on the vaccine being developed.

Amplitude believes this approach could potentially provide stronger activity at lower doses while also making RNA products easier to manufacture at scale.

Why the Partnership With Lilly Matters

Developing a vaccine is not only about finding a promising technology.

A vaccine candidate also needs to move through preclinical testing, clinical trials, manufacturing, regulatory review and eventually commercial production.

That is where Lilly's role becomes important in this collaboration.

Amplitude will focus on optimizing its taRNA technology and conducting selected preclinical research activities under agreed research plans.

Lilly will take responsibility for additional preclinical development, clinical development, manufacturing, regulatory activities and commercialization.

This gives the two companies clearly defined roles as the programs move forward.

Lilly Gets Rights to the Collaboration Targets

Under the agreement, Lilly will receive exclusive, target-specific rights to develop and commercialize products that come from the collaboration targets.

The specific infectious diseases being targeted have not been disclosed.

Lilly can also choose to add up to two additional infectious disease targets.

The financial terms of the agreement were not disclosed in the announcement.

Amplitude Wants to Expand What RNA Medicines Can Do

Amplitude is developing taRNA as part of a broader strategy to build an in vivo RNA platform.

The company is working on both taRNA and lipid nanoparticle, or LNP, technologies.

According to Amplitude, these technologies could be used across different types of vaccines and medicines.

The company's work is not limited to infectious diseases. Its platform is also being explored for protein replacement, immunology and genetic medicine applications.

Dr. Cory Sago, chief executive officer of Amplitude Therapeutics, said the Lilly collaboration gives the company an opportunity to validate its taRNA platform across several vaccine programs while using Lilly's global development, manufacturing and commercial capabilities.

How the Vaccine Development Work Will Be Divided

The collaboration gives each company a different part of the development process.

Amplitude will lead taRNA optimization and selected preclinical research activities.

Lilly will handle additional preclinical work after the agreed research activities, followed by clinical development if the programs advance.

Lilly will also oversee manufacturing, regulatory activities and commercialization for licensed products.

This structure allows Amplitude to focus on the technology while Lilly brings its larger development and commercial infrastructure to the programs.

Potential Benefits of the taRNA Approach

RNA-based technologies have become an important area of vaccine research, but different RNA platforms have different technical challenges.

Amplitude is developing taRNA to provide more flexibility in how RNA components are designed and delivered.

The company believes separating the replicase and antigen-encoding components may allow researchers to optimize each part independently.

Potential advantages being explored include higher potency, lower dosing requirements and improved manufacturing scalability.

These benefits are still part of the technology's development story and will need to be demonstrated through research and clinical development.

Infectious Disease Programs Will Be the Initial Focus

The first programs under the agreement will target infectious diseases with high unmet medical needs.

The companies have not disclosed the specific diseases or vaccine candidates involved.

The ability to add two additional targets gives Lilly room to expand the collaboration if the initial programs support further development.

This could allow the taRNA platform to be tested across multiple infectious disease applications rather than being limited to a single vaccine program.

Amplitude Therapeutics' Growing RNA Platform

Amplitude Therapeutics was founded in 2022 and is based in Boston.

The company is developing a next-generation taRNA platform for medicines and vaccines.

Its research covers several areas, including infectious diseases, protein replacement, immunology and genetic medicines.

The platform is designed to support RNA-based products that can potentially provide strong in vivo expression while remaining flexible and scalable from a manufacturing perspective.

Amplitude is also a member of the Lilly Gateway Labs community.

Backing From Life Sciences Investors and Organizations

Amplitude is backed by life sciences investors including ARCH Venture Partners, Newpath Partners and Alta Partners.

The company has also received non-dilutive support from organizations including BARDA, CEPI and the Gates Foundation.

This combination of private investment and non-dilutive funding has supported the company's work on its RNA technology platform.

What Happens Next

The companies will now work through the agreed research programs to identify and optimize taRNA vaccine candidates.

Amplitude will lead the initial taRNA optimization and selected preclinical activities, while Lilly will take on additional development responsibilities for programs that move forward.

The specific vaccine targets, development timelines and future clinical plans have not yet been disclosed.

The progress of these programs will determine how far the taRNA technology can advance as a platform for infectious disease vaccines.